NCT05491655 High Intensity His Bundle Pacing in Heart Failure Patients With Narrow QRS Outcome Study
| NCT ID | NCT05491655 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Miulli General Hospital |
| Condition | Cardiac Conduction System |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2023-03-29 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2023-03-29 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cardiac Resynchronization Therapy (CRT) decreases heart failure hospitalizations and mortality and increases left ventricular Ejection Fraction (EF) in patients with dilated cardiomyopathy, left bundle branch block and QRS duration \>130msec. His bundle pacing has a similar effect in this category of patients. However, CRT is not beneficial in heart failure (HF) patients with narrow QRS. His-bundle pacing delivers physiological ventricular activation and has been shown to improve acute hemodynamic function in patients with heart failure, a prolonged PR interval, and either a narrow QRS or RBBB through AV delay optimization. We observed an acute hemodynamic effect during application of higher pacing output (3.5 Volts/1 msec) in HF patients with dilated or ischemic cardiomyopathy and narrow QRS independently of the paced QRS duration or AV delay shortening. This is a single-center, prospective randomized single-blinded study, recruiting a sub-population of patients with heart failure (dilated or ischemic cardiomyopathy, EF\<50%, narrow QRS (\<110 msec), in optimal medical treatment who have an indication for ICD.
Eligibility Criteria
Inclusion Criteria: * Aged 18 or above * Ventricular Ejection Fraction (EF) \< 50%; BNP needs to be ≥250ng/L or N Terminal-pro BNP≥600ng/L for patients with EF 36-50% and they should have an ICD indication * New York Heart Association (NYHA) class I-IV * Narrow QRS duration (≤110ms) on 12 lead ECG Exclusion Criteria: * Other serious medical condition with life expectancy of less than 1 year * Lack of capacity to consent * Pregnancy * Previous aortic valve surgery
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05491655 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Cardiac Conduction System. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05491655 currently recruiting?
Yes, NCT05491655 is actively recruiting participants. Contact the research team at g.katsouras@miulli.it for enrollment information.
Where is the NCT05491655 trial being conducted?
This trial is being conducted at Acquaviva delle Fonti, Italy.
Who is sponsoring the NCT05491655 clinical trial?
NCT05491655 is sponsored by Miulli General Hospital. The trial plans to enroll 34 participants.